First-in-human Study of OVM-200 As a Therapeutic Cancer Vaccine

Inclusion Criteria:

1. Histologically confirmed metastatic or locally advanced inoperable NSCLC,ovarian cancer, or prostate cancer that have already received at least 1 lineof approved cancer therapy and either: exhausted current recognized treatmentoptions; or are stable in a planned treatment-free interval followingcompletion of a set course of treatment; or in the case of prostate cancer, arecurrently stable on an antihormonal treatment.

2. Are not receiving active cancer treatment other than supportive therapies orandrogen deprivation therapies for prostate cancer, which may be continued,and, in the opinion of the investigator, are not anticipated to require furtherapproved cancer treatment options until the Week 8 assessment (up to 9 weeks)after the first dose of OVM-200 per standard of care.

3. At least 1 measurable lesion that can be accurately assessed at baseline bycomputed tomography (CT)/magnetic resonance imaging (MRI) and is suitable forrepeated assessment (NSCLC only).

4. Age ≥ 18 years and ≤ 75 years. 5. Eastern Cooperative Oncology Group (ECOG)performance status ≤ 2 (Section 7.2.6).

5. Predicted life expectancy ≥ 3 months. 7. Adequate bone marrow, renal, andhepatic function.

Exclusion Criteria:

1. Known history or evidence of significant immunodeficiency due to underlying illness.Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisolone equivalent) or other immunosuppressive medicationswithin 14 days of the first dose of study drug. Inhaled or topical steroids andadrenal replacement steroids are permitted in the absence of autoimmune disease.

2. Patients with a history of or active, known, or suspected autoimmune disease or asyndrome that requires systemic or immunosuppressive agents. Patients with vitiligo,type I diabetes mellitus, residual hypothyroidism due to autoimmune disease onlyrequiring hormone replacement, psoriasis not requiring systemic treatment, orconditions not expected to recur in the absence of an external trigger are permittedto enrol.

3. Prior therapy with an anticancer vaccine; anti-PD-1, anti-PD-L1, anti-PD-L2,anti-CD137, or anti-CTLA-4 antibody; or any other antibody or drug specificallytargeting T-cell co-stimulation or immune checkpoint pathways in the 28 days beforethe first dose of study drug.

4. Administration of an investigational drug in the 28 days or 6 half-lives (whicheveris longer) before the first dose of study drug.

5. Major surgery or treatment with any chemotherapy, or radiation therapy for cancer inthe 28 days before the first dose of study drug.

6. Active infection requiring antibiotics or physician monitoring, or recurrent fevers (> 38.0°C) associated with a clinical diagnosis of active infection.

7. Active viral disease, positive test for hepatitis B virus using hepatitis B surfaceantigen test, or positive test for hepatitis C virus (HCV) using HCV ribonucleicacid or HCV antibody test indicating acute or chronic infection. Positive test forhuman immunodeficiency virus (HIV) or acquired immunodeficiency syndrome; testing isnot required in the absence of history.

8. Receipt of any vaccine within 28 days before the first dose of study drug.

9. Other prior malignancy within the previous 3 years, except for local ororgan-confined early stage cancer that has been definitively treated with curativeintent and does not require ongoing treatment, has no evidence of residual disease,and has a negligible risk of recurrence and is therefore unlikely to interfere withthe primary and secondary endpoints of the study, including response rate and safetyand tolerability.

10. Symptomatic brain metastases or any leptomeningeal metastasis.

11. Any serious or uncontrolled medical disorder (including cardiovascular, respiratory,renal, or autoimmune disease) that, in the opinion of the investigator or themedical monitor, may increase the risk associated with study participation or studydrug administration, impair the ability of the patient to receive protocol therapy,or interfere with the interpretation of study results.

12. History of allergic reaction or hypersensitivity to any component of the OVM-200therapeutic vaccine or adjuvant.